Cancer is responsible for significant health problems in populations of women in the United States and throughout the world. In particular, gynecological cancers, including ovarian, uterine, cervical, and vuvlar cancers, are responsible for over 5,000 deaths in the United States each year. Although recent years have seen advances in detection and treatment of these cancers, mortality rates remain significantly high.
Cervical cancer can be prevented and possibly cured if detected early enough in its precancerous or precursor stages. There are a variety of known techniques for the early detection of cervical cancer. Most of these techniques include the scraping or sampling of tissue from the uterine or endocervical canal using a spatula or brush collection device. Tissues or cells obtained with these devices would be subjected to cytological or other examinations, such as the Papanicolaou or Pap smear.
The present invention relates to an improved cell collection device and method for obtaining tissue samples from the uterus of a patient. A number of devices have been developed to collect samples from the cervix including cotton swabs introduced into the uterine canal, wet spatulas, wooden spatulas, aspiration through plastic or glass pipettes, and endocervical sample collection brushes. Examples of such devices are disclosed in U.S. patents to MacLean (U.S. Pat. No. 2,955,591), Antonides (U.S. Pat. No. 3,626,470), Oster (U.S. Pat. No. 3,815,580), Vermes (U.S. Pat. No. 3,877,464), Levene (U.S. Pat. No. 3,881,464), Milan (U.S. Pat. No. 3,945,372), Nollan (U.S. Pat. No. 4,127,113), White (U.S. Pat. No. 4,175,008), Kist (U.S. Pat. No. 4,700,713), Bayne (U.S. Pat. No. 4,754,764), Bayne et al (U.S. Pat. No. 4,762,133), Bayne (U.S. Pat. Nos. 4,754,764 and 4,873,992), Bucaro (U.S. Pat. No. 4,862,899), Samuels (U.S. Pat. No. 4,953,560), Worthen et al. (U.S. Pat. No. 5,445,164), Sak (U.S. Pat. No. 5,787,891), Leet et al. (U.S. Pat. No. 5,795,309), and Wallach (U.S. Pat. Nos. 6,387,058 and 6,740,049)
Although cell collection brushes are well known and widely used, there are many disadvantages associated with the present cell collection brushes. One disadvantage is the dispersal of the collected biological material from the cell collection brushes into a sample vial. During use, a collection brush is inserted inside the vagina and is then rotated one or more full turns to scrape off tissue material from the opening of the endocervical canal. After the cell sample is collected, the collection brush is either swirled in a specimen vial containing cell preservative to release cells from the brush or a portion of the brush is detached into a specimen collection vial for transportation to a laboratory for processing.
A disadvantage associated with this type of brush assembly is that a number of cells remain attached to the collection brush even after the brush is agitated in solution. Since it is important to obtain a large enough sample of cells to ensure the chances of detecting abnormal cells in a sample, it would therefore be highly desirable to have a device which increases the total number of exocervical and endocervical cells collected from a patient.